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Generic Name: sarilumab
Dosage Form: Injection
Date of Approval: May 22, 2017
Company: Sanofi and Regeneron Pharmaceuticals, Inc.

Treatment for: Rheumatoid Arthritis

FDA Approves Kevzara

The U.S. Food and Drug Administration (FDA) has approved Kevzara (sarilumab), an interleukin-6 (IL-6) receptor antagonist indicated for treatment of adult patients with moderately to severely active rheumatoid arthritis who have had an inadequate response or intolerance to one or more disease-modifying antirheumatic drugs (DMARDs).

Medication Guide

Read this Medication Guide before you start treatment, and each time you get a refill. There may be new information. This information does not take the place of talking with your healthcare provider about your medical condition or treatment.

Important information

Kevzara can cause serious side effects including:

  • Serious Infections. Kevzara is a prescription medicine that affects your immune system. It can lower the ability of your immune system to fight infections. Some people have serious infections while using Kevzara, including tuberculosis (TB), and infections caused by bacteria, fungi, or viruses that can spread throughout the body. Some people have died from these infections. Your healthcare provider should test you for TB before starting treatment.
    • Your healthcare provider should monitor you closely for signs and symptoms of TB during treatment. You should not start treatment if you have any kind of infection unless your healthcare provider says it is okay.

      Before starting treatment, tell your healthcare provider if you:
      • think you have an infection or have symptoms of an infection, with or without a fever:
        • sweats or chills
        • muscle aches
        • cough
        • shortness of breath
        • blood in your phlegm
        • weight loss
        • warm, red or painful skin or sores on your body
        • diarrhea or stomach pain
        • burning when you urinate or urinating more often than normal
        • feeling very tired
    • are being treated for an infection.
    • get a lot of infections or have infections that keep coming back.
    • have diabetes, HIV, or a weak immune system. People with these conditions have a higher chance of getting infections.
    • have TB, or have been in close contact with someone with TB.
    • live or have lived, or have traveled to certain parts of the country (such as the Ohio and Mississippi River valleys and the Southwest) where there is an increased chance of getting certain fungal infections (histoplasmosis, coccidioidomycosis, or blastomycosis). These infections may happen more often or become more severe if you use Kevzara. Ask your healthcare provider if you do not know if you have lived in an area where these infections are common.
    • have or have had hepatitis.
    After starting Kevzara, call your healthcare provider right away if you have any symptoms of an infection.
  • Changes in certain laboratory test results. Your healthcare provider should do blood tests before you start Kevzara, four to eight weeks after starting Kevzara, and then every three months during treatment to check for:
    • low neutrophil count. Neutrophils are white blood cells that help the body fight off bacterial infections. A low neutrophil count is common with Kevzara, and can be severe.
    • low platelet count. Platelets are blood cells that help with blood clotting and stop bleeding.
    • increase in certain liver function tests. An increase in certain liver function tests is common with Kevzara, and can be severe.
    Your healthcare provider may not prescribe Kevzara if your neutrophil or platelet counts are too low, or your liver function tests are too high. Your healthcare provider may stop your treatment for a period of time or change your dose if needed because of changes in these blood test results. Your healthcare provider should do blood tests four to eight weeks after starting Kevzara and then every six months during treatment to check for an:
    • increase in blood cholesterol levels.
  • Tears (perforation) of the stomach or intestines. Tell your healthcare provider if you have had a condition known as diverticulitis (inflammation in parts of the large intestine) or ulcers in your stomach or intestines. Some people using Kevzara get tears in their stomach or intestine. This happens most often in people who also take nonsteroidal antiinflammatory drugs (NSAIDs), corticosteroids, or methotrexate. Call your healthcare provider right away if you have fever and stomach (abdominal) pain that does not go away.
  • Cancer. Kevzara may increase your risk of certain cancers by changing the way your immune system works. Tell your healthcare provider if you have ever had any type of cancer.

See Kevzara side effects for more information about side effects.

What is Kevzara?

Kevzara is an injectable prescription medicine called an Interleukin-6 (IL-6) receptor blocker. It is used to treat adults with moderately to severely active rheumatoid arthritis (RA) after at least one other medicine called a disease modifying antirheumatic drug (DMARD) has been used and did not work well or could not be tolerated.

It is not known if Kevzara is safe and effective in children.

Who should not use Kevzara?

Do not use Kevzara if you are allergic to sarilumab or any of the other ingredients. See the end of this Medication Guide for a complete list of ingredients.

Before starting treatment, talk to your healthcare provider about all of your medical conditions, including if you:

  • have an infection. See Important information.
  • have liver problems.
  • have had stomach (abdominal) pain or been diagnosed with diverticulitis or ulcers in your stomach or intestines.
  • have recently received or are scheduled to receive a vaccine. People who take Kevzara should not receive live vaccines.
  • plan to have surgery or a medical procedure.
  • are pregnant or plan to become pregnant. It is not known if Kevzara will harm your unborn baby.
    Pregnancy Registry: Sanofi has a registry for pregnant women who use Kevzara. The purpose of this registry is to gather information about the health of the pregnant mother and her baby. If you are pregnant or become pregnant while using Kevzara, talk to your healthcare provider about how you can join this pregnancy registry or call 1-877-311-8972 to enroll.
  • are breastfeeding or plan to breastfeed. It is not known if Kevzara passes into your breast milk. Talk to your healthcare provider about the best way to feed your baby during treatment.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Especially tell your healthcare provider if you use:

  • any other medicines to treat your RA. You should not take rituximab (Rituxan), etanercept (Enbrel), infliximab (Remicade), anakinra (Kineret), adalimumab (Humira), abatacept (Orencia), certolizumab (Cimzia), golimumab (Simponi), tocilizumab (Actemra), or tofacitinib (Xeljanz) while you are using Kevzara. Using Kevzara with these medicines may increase your risk of infection.
  • medicines that affect the way certain liver enzymes work. Ask your healthcare provider if you are not sure if your medicine is one of these.

Know the medicines you take. Keep a list of them to show to your healthcare provider and pharmacist when you get a new medicine.

How should I use Kevzara?

  • See the detailed Instructions for Use that come with your prescription for instructions about the right way to prepare and give your injections at home.
  • Kevzara is given as an injection under the skin (subcutaneous injection).
  • Kevzara is available as a single-use pre-filled syringe. Your healthcare provider will prescribe the dose that is best for you.
  • If your healthcare provider decides that you or a caregiver can give the injections of Kevzara at home, you or your caregiver should receive training on the right way to prepare and inject Kevzara. Do not try to use the injections until you have been shown the right way by your healthcare provider.
  • Inject one dose every two weeks.

Kevzara side effects

Kevzara can cause serious side effects, including:

  • See Important information.
  • Serious allergic reactions. Serious allergic reactions can happen with Kevzara. Get medical attention right away if you have any of the following signs of a serious allergic reaction:
    • shortness of breath or trouble breathing
    • swelling of the lips, tongue, or face
    • chest pain
    • feeling dizzy or faint
    • moderate or severe stomach (abdominal) pain or vomiting

Common side effects of Kevzara include:

  • injection site redness
  • upper respiratory tract infection
  • urinary tract infection
  • nasal congestion, sore throat, and runny nose

These are not all of the possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects to sanofi-aventis at 1-800-633- 1610.

How should I store Kevzara?

  • Store Kevzara in the refrigerator at 36°F to 46°F (2°C to 8°C). Store the injections in the original carton until use to protect it from light.
  • Do not freeze the injections.
  • Do not shake the injections.
  • The injections may be stored at room temperature up to 77°F (25°C) for up to 14 days in the original outer carton.
  • Throw away Kevzara if it has been kept at room temperature and not been used within 14 days.

General Information about the safe and effective use of Kevzara.

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use this medicine for a condition for which it was not prescribed. Do not give it to other people, even if they have the same symptoms you have. It may harm them.

You can ask your healthcare provider or pharmacist for information that is written for health professionals.

What are the ingredients in Kevzara?

Active Ingredient: sarilumab

Inactive Ingredients: arginine, histidine, polysorbate 20, sucrose, and Water for Injection, USP.

More about Kevzara (sarilumab)

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